eurocognitive function among HIV-infected infants with severe pneumonia receiving empirical treatment for cytomegalovirus and tuberculosis

Makerere University0 个研究点目标入组 105 人开始时间: 2022年1月17日最近更新: 2024年9月9日

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•Cohort of HIV positive children with severe pneumonia:
•1. Aged between 28 and 365 days
•2. Participating in the EMPIRICAL trial
•3. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (=1 World Health Organization criteria)
•4. Pneumonia, defined as chest indrawing or fast breathing for age (for infants aged 28 to 60 days, =60 breaths per minute; for infants aged 61 to 365 days, =50 breaths per minute)
•5. HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load)
•6. Informed consent obtained from caregivers
•Cohort of HIV negative children with severe pneumonia:
•1. Aged between 28 and 365 days
•2. Current hospitalization due to pneumonia with criteria for parenteral antibiotics (=1 World Health Organization criteria)
•3. Pneumonia, defined as chest indrawing or fast breathing for age (for infants aged 28 to 60 days, =60 breaths per minute; for infants aged 61 to 365 days, =50 breaths per minute)
•4. Informed consent obtained from caregivers
•Cohort of HIV positive children without pneumonia:
•1. Aged between 28 and 365 days
•2. HIV-confirmed infection (with at least one molecular method: DNA PCR or RNA PCR/viral load)
•3. Informed consent obtained from caregivers

•1. Clinical TB (pulmonary or extrapulmonary) diagnosis. Defined as the necessity of TB treatment prescribed by a physician, known bacteriologically confirmed TB case (at least one biological specimen positive by culture or Xpert MTB/RIF) at the moment of randomization, previously treated for TB or currently on treatment for TB, or documented evidence of close TB exposure.
•2. Pure wheezers. Defined as a clear clinical improvement after a bronchodilator test.
•3. Active malignancies, systemic immunosuppressive medications, or evidence of condition other than HIV and pneumonia
•4. Weighing <2.5 kg
•5. Hemoglobin less than <6 g/dl in the screening blood test or in a test done in the last 48 h
•6. Neutropenia <500 /mm³ in the screening blood test or in a test done in the last 48 h

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